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U.S. Department of Health and Human Services

Consumers: Case Study 2 – Dietary Supplement

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Jack J. is a 26-year-old single man working as a construction worker and is a self-described body-builder. He went to the emergency room at his local hospital on April 2, 2012 because he felt tired and weak, and also had a cough and shortness of breath, which had become worse over the last two weeks.

Jack takes daily doses of two body-building supplements made by XYZ Nutritionals. He takes six to eight pills per day and has been doing so for the past 2-3 years. The ingredients listed on the labels for each of the supplements include:

  • Dietary Supplement A for Body Builders containing Ma Huang (ephedrine), guarana (caffeine), chromium picolinate and L-carnitine.
  • Dietary Supplement B for Body Builders containing HCA (garcinia cambogia extract), Ma Huang, guarana, willow bark extract (salicylates) and chromium picolinate).

Jack is a diabetic and uses daily insulin (40 units of NPH insulin every morning (q AM)) to control his blood sugar. He also is a non-smoker and drinks alcohol only occasionally, once every 10-14 days.

The emergency room nurse took Jack’s blood pressure when he arrived and it was very high. The emergency room doctor examined Jack, noted the high blood pressure, and decided to perform an echocardiogram, a test that shows the heart’s size, structure, and function. The test showed Jack’s heart was enlarged and had a reduced pumping capacity. The doctor explained these are symptoms of congestive heart failure, a serious condition. The doctor told Jack it was likely the body-building supplements had caused his heart problems. He recommended that Jack stop using them. Jack was given a prescription for a blood pressure medication and told to have it filled at his local pharmacy. The doctor also recommended that Jack follow up with his primary care provider.

Section A – About the Problem

What kind of problem was it? (Check all that apply)

Did any of the following happen? (Check all that apply)



For a problem with a product, including

  • prescription or over-the-counter medicine
  • biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments and bone) and gene therapies
  • nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods
  • tobacco and nicotine products, including those to help you quit
  • cosmetics or make-up products
Go to Section B

For problems with a medical device, including

  • any health-related test, tool, or piece of equipment
  • health-related kits, such as glucose monitoring kits or blood pressure cuffs
  • implants, such as breast implants, pacemakers, or catheters
  • other consumer health products, such as contact lenses, hearing aids, and breast pumps
Go to Section C
(Skip Section B)
Section B – About the Product
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
Do you still have the product in case we need to evaluate it? (Do not send the product to FDA.
We will contact you directly if we need it.)
Go to Section D (skip section C)
Section C – About the Medical Device
Was someone operating the medical device when the problem occurred?
If yes, who was using it?

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.):

Go to Section D
Section D – About the Person Who Had the Problem
Sex
Go to Section E
Section E – About the Person Filling Out This Form

We will contact you only if we need additional information. Your name will not be given out to the public.

Did you report this problem to the company that makes the product (the manufacturer)?
May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?
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